Senior Mechanical Engineer II

Gaithersburg, Maryland

Job Title: Senior Mechanical Engineer II
Location: Gaithersburg, MD (Onsite)
Hours/Schedule: Monday – Friday, Standard Business Hours
Compensation: $115,000 – $140,000 + bonus eligibility
Type: Direct Hire

Overview
A growing life sciences and bioprocessing organization is seeking a Senior Mechanical Engineer II to support the design and development of advanced mechanical systems and sterile consumable technologies used in GMP manufacturing environments. This is a highly collaborative, hands-on engineering role offering exposure to innovative bioprocessing technologies, cross-functional development teams, and complex product development initiatives.

Responsibilities

  • Lead mechanical design and development for GMP manufacturing systems and consumables
  • Create CAD models, drawings, BOMs, and ECOs in SolidWorks
  • Perform tolerance analysis, FEA, and root cause investigations
  • Support prototyping, testing, and design verification activities
  • Design sterile single-use bioprocessing and fluid handling systems
  • Develop and execute validation and testing protocols
  • Support design transfer and DHF documentation
  • Collaborate with engineering, manufacturing, quality, and suppliers
  • Mentor junior engineers and provide technical guidance
  • Ensure compliance with GMP, regulatory, and engineering standards
  • Develop SOPs and engineering documentation

Requirements
  • B.S. in Mechanical Engineering required; M.S. preferred
  • 8+ years of mechanical design experience
  • Experience in medical device, bioprocessing, pharma, or regulated industries
  • Hands-on experience with sterile single-use systems or fluid assemblies
  • Strong knowledge of fluid systems, pumps, valves, manifolds, and flow paths
  • Experience with sealing interfaces, tolerance analysis, and complex mechanical systems
  • Proficient in SolidWorks; PDM experience preferred
  • Familiarity with DFx, manufacturability, reliability, and cost optimization
  • Experience with bioprocessing systems such as bioreactors or filtration technologies
  • FEA experience preferred; COMSOL is a plus
  • Knowledge of GMP environments and cleanroom-compatible design
  • Familiarity with ISO 13485, ISO 9001, ISO 10993, ISO 14971, and design controls
  • Experience with validation, testing, and engineering documentation
  • Prototyping and fabrication experience preferred (CNC, molding, 3D printing, etc.)
  • Strong communication, collaboration, and problem-solving skills
  • Ability to travel domestically up to 10–15%


Benefits
Our client provides a comprehensive benefits package including medical, dental, and vision coverage, retirement savings options, paid time off, professional development opportunities, and bonus eligibility.


#M-3
#LI-MM1
Ref: #558-Scientific


Type: Direct-Hire

Experience: 0

Category: Engineering

Contractor Work Model: Onsite

Brand: Joulé

Shift: On-Site

Compensation Range: 115000.00 - 140000.00

Job ID: 351217

Date Posted: 05/26/2026

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